Evaluation of the automated ADVIA centaur® XP syphilis assay for serological testing

Abstract

We evaluated the performance of the ADVIA Centaur XP Syphilis assay (Siemens Healthcare Diagnostics, Tarrytown, NY, USA) using samples previously tested on the ARCHITECT i4000SR system (Abbott Diagnostics, Lake Forest, IL, USA) and confirmed by the Treponema pallidum particle agglutination assay (TPPA) (SERODIA-TPPA, Fujirebio Diagnostics Inc., Malvern, PA, USA). Clinical patient information was included to aid resolution of discordant samples where available. Precision, interference, and cross-reactivity were also assessed. Relative to patient clinical status, the sensitivity of both the ADVIA Centaur XP and the ARCHITECT assays was 100% (95% CI, 93.9–100), and the specificity of the ADVIA Centaur XP assay was 95.5% (95% CI, 90.4–98.3), which was slightly higher than that of the ARCHITECT assay at 93.9% (95% CI, 88.4–97.3). Overall agreement relative to patient clinical status was 96.9% (95% CI, 93.3–98.8) for the ADVIA Centaur XP assay and 95.8% (95% CI, 91.9–98.2) for the ARCHITECT assay. Overall agreement between the two automated assays was 96.9% (95% CI, 93.3–98.8). ADVIA Centaur XP assay precision was <5% at all index values tested. No significant interference was observed for lipemia or hemolysis; a small effect was seen with some samples for bilirubin. The assay exhibited no significant cross-reactivity with a number of potential interfering factors. The ADVIA Centaur XP Syphilis assay can be considered a sensitive and accurate assay for identification of treponemal antibodies in screening populations as well as patients presenting with suspicion of syphilitic infection.